Home NDC 82804-097 Stool Softener Laxative
Product NDC 82804-097
11-digit product format 828040097
Labeler code 82804
Product ID 82804-097_4a31ab87-74a2-4354-b2be-f00f62d6cf29
Type HUMAN OTC DRUG
Nonproprietary name DOCUSATE SODIUM
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Proficient Rx LP
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-11-15
Substance DOCUSATE SODIUM
Active strength 100 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Stool Softener Laxative
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCUSATE SODIUM 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F05Q2T2JA0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1115005 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82804-097-00 Stool Softener Laxative 100 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 100 2 82804-097-30 Stool Softener Laxative 30 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82804-097 STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PROFICIENT RX LP] 2 Current NDC, 2 package rows 20240904_ccfa095c-77f0-41ff-84f8-e02d983c7c74.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 17 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82804-097-00 82804009700 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (82804-097-00) 2024-04-05 No No Current 82804-097-30 82804009730 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (82804-097-30) 2024-08-28 No No Current